Completed

Photobiomodulation Therapy for Fatigue and Behavioural Status in Hashimoto's Thyroiditis

What is being tested

Photobiomodulation Therapy

+ Sham

Other

Who is being recruted

Anxiety Disorders+12

+ Autoimmune Diseases

+ Behavior

From 18 to 65 Years

+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Interventional

Study Start: January 2021

See protocol details

Summary

Principal SponsorIstanbul Medipol University Hospital

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 28, 2021

Actual date on which the first participant was enrolled.

This clinical trial explores the effects of photobiomodulation therapy (PMBT) on people with Hashimoto's thyroiditis, a condition where the immune system attacks the thyroid gland. This therapy involves using light to stimulate cells, potentially improving thyroid function and other related symptoms. Many people with Hashimoto's thyroiditis experience fatigue and changes in their behavior. This study aims to provide new insights into how PMBT, combined with the standard treatment using LT4 medication, might help reduce fatigue, improve sleep quality, and enhance overall behavioral well-being for these patients. Participants in the study will receive PMBT alongside their regular LT4 treatment. The therapy is applied through a process that stimulates the cells using light, aiming to bring about positive changes in the body. The study will carefully monitor changes in participants' fatigue levels, sleep patterns, and behavioral status to evaluate the effectiveness of this combined treatment approach. The potential benefits of this study could lead to improved quality of life for those dealing with the challenging symptoms of Hashimoto's thyroiditis, though specific risks are not detailed in the study description.

Official TitleThe Effect of Photobiomodulation Therapy on Fatigue and Behavioural Status in Patients With Hashimoto's Thyroiditis

NCT06735040

Principal SponsorIstanbul Medipol University Hospital

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Anxiety DisordersAutoimmune DiseasesBehaviorMental DisordersBehavioral SymptomsDepressionEndocrine System DiseasesFatigueImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsThyroid DiseasesThyroiditisThyroiditis, AutoimmuneHashimoto Disease

Criteria

1 inclusion criteria required to participate

The study included patients over the age of eighteen years who were diagnosed with HT by a specialist physician and followed up with LT4 treatment.

1 exclusion criteria prevent from participating

Exclusion criteria were acute infection, use of immunosuppressants, immunostimulants and drugs that interfere with the production, transport and metabolism of thyroid hormones (e.g. corticosteroids, lithium and amiodarone), thyroid nodules, tracheal stenosis, history of serious illness (e.g. cancer, ischaemic coronary artery disease, stroke, renal and liver failure), history of exposure to ionising radiation or neoplasia in the cervical region, malignancy and thyroid surgery; cancer, ischaemic coronary artery disease, stroke, renal and hepatic failure), history of exposure to ionising radiation or neoplasia in the cervical region, history of malignancy and thyroid surgery, hypothyroidism caused by postpartum thyroiditis, pregnancy and lactation, neurological and psychiatric disorders.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

All patients diagnosed with HT in the study were receiving LT4 treatment. In the PMBT group, in addition to thyroid hormone replacement therapy, a continuous wave GaAIAs type diode laser device (Intelect® Mobile Laser, Model No: 2779, Production Year: 2016; Chattanooga Group) was also applied to the thyroid gland in a 0.07 cm² treatment area. Continuous mode at 850 nm wavelength, 100 mW output power, 1.43 W/cm2 power density and 28.57 J/cm2 energy density (28.57 J/cm2 =100 Mw x 20 s/0.07) were used during the photobiomodulation therapy.

Group II

Sham

In the sham PMBT group, the probe was placed similarly to the treatment group. The screen of the laser device was active; however, the energy was set to 0 J and the power to 0 Mw, and the same procedures were also performed.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Sümeyye TUNÇ

Istanbul, Turkey (Türkiye)Open Sümeyye TUNÇ in Google Maps

CompletedOne Study Center